Cleared Traditional

K881589 - 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881589 · Continental X-Ray Corp. · Radiology device
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Jul 1988
Decision
96d
Days
Class 2
Risk

K881589 is an FDA 510(k) clearance for the 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400. Classified as Device, Spot-film (product code IXL), Class II - Special Controls.

Submitted by Continental X-Ray Corp. (Chicago, US). The FDA issued a Cleared decision on July 18, 1988 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1670 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Continental X-Ray Corp. devices

Submission Details

510(k) Number K881589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1988
Decision Date July 18, 1988
Days to Decision 96 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 107d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXL Device, Spot-film
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1670
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.